Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Efavirenz, Lamivudine...

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Wed Sep 16, 2009 7:30am EDT

Mylan's Matrix Receives Tentative FDA Approval Under PEPFAR for Efavirenz,
Lamivudine and Tenofovir Disoproxil Fumarate Tablets


PITTSBURGH, Sept. 16 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today
announced that its privately held Indian subsidiary, Matrix Laboratories
Limited, has received tentative approval from the U.S. Food and Drug
Administration (FDA) under the President's Emergency Plan for AIDS Relief
(PEPFAR) for its New Drug Application (NDA) for Efavirenz, Lamivudine and
Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

Mylan's product represents the first-ever fixed-dose combination of Efavirenz,
Lamivudine and Tenofovir Disoproxil Fumarate and now provides Matrix with
numerous Tenofovir combination product opportunities. This new drug adds to
the Matrix portfolio of important treatments for HIV/AIDS. The product may be
used for either first- or second-line treatment in adults. People use
second-line therapies if and when they develop resistance to initially
prescribed treatments.

Mylan President Heather Bresch said: "This product represents yet another
important advance in our continuing fight against the global epidemic of
HIV/AIDS. By combining three antiretroviral (ARV) products into a once-daily
dose, we can dramatically improve the quality of care for people living with
HIV/AIDS in emerging markets. Lower pill burden also increases the likelihood
that patients adhere to treatment. This innovation also adds another
affordable option to our large and rapidly growing portfolio of
life-sustaining ARV products."

The FDA's tentative approval under PEPFAR means that Matrix's product meets
all of the agency's manufacturing quality, safety and efficacy standards.
Although existing patents or exclusivity prevent its marketing in the U.S.,
the product will be eligible for purchase outside the U.S. in many developing
countries.

Matrix's wide range of ARV products includes active pharmaceutical ingredients
and first- and second-line finished doses. The company's emphasis on producing
affordable products has allowed it to drive down the average annual cost per
patient of effective therapies. Approximately 30% of HIV/AIDS patients in
developing countries who are receiving treatment depend on Matrix ARV
products.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical
companies in the world and provides products to customers in more than 140
countries and territories. The company maintains one of the industry's
broadest and highest quality product portfolios supported by a robust product
pipeline; operates the world's third largest active pharmaceutical ingredient
manufacturer; and runs a specialty business focused on respiratory and allergy
therapies. For more information, please visit www.mylan.com.

SOURCE  Mylan Inc.

Michael Laffin (Media), +1-724-514-1968, or Dan Crookshank (Investors),
+1-724-514-1813, both of Mylan Inc.
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